- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …domestic/international travel. **Job Description** + Develop and implement global CMC regulatory strategies for late-stage development, marketing applications ... of regulatory submissions (IND/IMPD/NDA/MAA, post-approval supplements). Determine regulatory CMC content and scientific/technical requirements to ensure… more
- Merck (Jackson, MS)
- …development through commercialization, with practical insight into how these operations generate CMC regulatory content + Understanding of CMC operations, ... source systems to regulatory documentation. Under the guidance of dCMC Regulatory Authoring Leadership, the Senior Specialist, Regulatory Authoring… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a ... Senior Manager of Statistics, you will provide statistical leadership in...design, analysis, and interpretation of Chemicals, Manufacturing, and Controls ( CMC ) study data throughout Pharmaceutical Sciences. We seek an… more
- BeOne Medicines (San Mateo, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring...throughout product life cycle. Escalate the critical issues to senior management timely. + Lead or contribute to development… more
- University of Michigan (Brighton, MI)
- Medical Assistant Senior ( CMC ) - Brighton Center for Specialty Care **Early Site Maintenance** We are performing updates and maintenance to our applicant ... employer. **Job Detail** **Job Opening ID** 263624 **Working Title** Medical Assistant Senior ( CMC ) - Brighton Center for Specialty Care **Job Title**… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Development, Site Manufacturing Sciences, QA, QC, Engineering, Supply Chain, Validation and Regulatory CMC to ensure aligned, efficient CMC execution ... and technology excellence. + Drive preparation and support of CMC content for regulatory submissions (initial filings,...strengthen supply reliability. + Collaborate closely with an assigned CMC Project Manager (who will provide you… more
- UTMB Health (Huntsville, TX)
- Technical Supervisor, Lab Serv - CMC - Estelle **Huntsville, Texas, United States** Allied Health UTMB Health Requisition # 2505527 The mission of Correctional ... workflow for the division; and communicate with staff, management, and senior leadership. **_ESSENTIAL JOB FUNCTIONS_** **:** . Responsible for recruitment, hiring,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …my knowledge. **Job Description** **Title: Global Manufacturing Sciences BioProcess Lead ( Sr . Manager )** **Location: Zurich, Switzerland / Lexington, MA** ... the biologics portfolio and provide technical expertise and leadership for regulatory interactions, including authoring CMC content for multi-site products.… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Manager , Supply Chain leads, develops, establishes, and manages the ... working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs, Marketing, Market Access, Medical Affairs, Drug Safety, Finance,… more
- ThermoFisher Scientific (Greenville, NC)
- …of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. + ... **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** ** Senior Director Project Mgmt - Oversight** At Thermo Fisher… more
- ThermoFisher Scientific (Greenville, NC)
- …of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. + ... cross-cultural experience. **Discover Impactful Work:** We are seeking a ** Senior Director, Project Management** in our **Oversight Respiratory Trials Team.**… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …including but not limited to healthcare antiseptic products. Under the mentorship of the Sr . RA Manager of Regulatory Affairs, they are responsible for ... **Job Description Summary** The Senior Regulatory Affairs (RA) Specialist within...requirements and support the proposed product claims. + Review CMC changes and determine regulatory reporting category… more
- Teva Pharmaceuticals (Weston, FL)
- Senior Manager R&D Global Program Leadership Date: Nov 13, 2025 Location: Weston, United States, Florida, 33325 Company: Teva Pharmaceuticals Job Id: 64961 **Who ... affect program delivery or quality. Work with all key departments-clinical, commercial, regulatory , CMC , operations, IP, TPO-to ensure program quality and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …is true to the best of my knowledge. **Job Description** **Title: Senior Manager , Commercial Biologics Product Science Lead** **Location: Lexington, MA ... biologics portfolio. In this role, you will be a senior subject matter expert across one or more products...products and provide strong technical expertise and leadership for regulatory interactions, including authoring CMC content for… more
- Pfizer (Groton, CT)
- ** Regulatory , Data Steward & Team Lead ( Sr . Manager )** Vault RIM process and system is highly dependent on accurate & complete metadata at all levels and ... scope, the position provides growth opportunities in Operations, Strategy, and Digital. ** Senior Manager :** + Formal leadership role of data coordinators… more
- Amgen (Thousand Oaks, CA)
- …partners such as Drug Substance Technologies, Drug Product Technologies, Product Quality, Regulatory CMC , and Supply Chain. The successful candidate will ... lives of patients while transforming your career. **Process Development Senior Scientist** **What you will do** Let's do this....method and validation and transfers + Contribute to global regulatory filings by authoring analytical CMC sections… more
- Otsuka America Pharmaceutical Inc. (Baton Rouge, LA)
- The Senior Manager , Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract ... submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors...of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP… more
- ThermoFisher Scientific (Wilmington, NC)
- …people and communities depend on - now and in the future. **Role:** CTM, Senior **Location:** US-Remote, East Coast HIGHLY preferred, may look at Central, but will ... complexity, and may assume regional lead or Clinical Study Manager responsibilities. **Key Responsibilities** : + Manages all clinical...members involved in the study set up (DM, Reg, CMC etc ): ensure feasibility report are exhaustive, Review… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Key Responsibilities** Senior Manager , Global External Manufacturing Biologics supports uninterrupted ... external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations. This… more
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